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Trial registered on ANZCTR


Registration number
ACTRN12620000652976
Ethics application status
Approved
Date submitted
23/04/2020
Date registered
5/06/2020
Date last updated
5/06/2020
Date data sharing statement initially provided
5/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
IMPLEMENT Study – Reducing vasovagal syncope and presyncope symptoms in plasma donors using applied muscle tension
Scientific title
Protocol for an effectiveness-implementation hybrid trial to assess the effectiveness of implementing applied muscle tension during plasma apheresis on reducing the incidence of syncope and presyncope symptoms: a cluster randomised step-wedged study
Secondary ID [1] 300794 0
None
Universal Trial Number (UTN)
Trial acronym
IMPLEMENT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Syncope 316660 0
Presyncope 316661 0
Condition category
Condition code
Neurological 314906 314906 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Applied Muscle Tension (AMT)

Applied Muscle Tension is a behaviour therapy technique, which has been found to increase cerebral blood flow and blood pressure (BP). The technique involves tensing and relaxing the large muscles (hamstrings, abdominal muscles) in the body

15 Australian Blood Donor Centres will be randomised in a step wedged fashion to commence a phased roll out of AMT during all eligible plasma donations at 2 weekly intervals, over a period of approximately 30 weeks.

Donors donating during the in the intervention phases will be instructed using written materials and face to face instruction from donor centre staff to: 1) cross their legs, 2) squeeze their inner thigh and abdominal muscles, and 3) stretch their ankles. They will be asked to hold this position for 5 seconds, then relax for 5 seconds, repeating the cycle 5 times, and then switch legs.

The average plasma donation time is 45minutes. All intervention phase donors will be instructed to perform AMT at different time points during the plasma donation (Needle In, 15min & 30min after donation starts, Needle out and before getting off the donor chair). Compliance to AMT will be by direct observation by Donor Centre staff and a post donation donor survey.



Intervention code [1] 317119 0
Prevention
Comparator / control treatment
Standard of care will be used as the control for the study. Standard of care is for staff to encourage donors to use AMT before getting up from the donation couch only, in accordance with current practice for the prevention of orthostatic intolerance.
Control group
Active

Outcomes
Primary outcome [1] 323579 0
Difference between intervention and control groups in the composite rates of phlebotomist-registered presyncope and syncopal reactions.

Data will be obtained through linkage to Lifeblood National Blood Management System donor records
Timepoint [1] 323579 0
72 hours after cessation of plasma donation
Primary outcome [2] 323580 0
Sustainability of the implementation of Applied Muscle tension during plasma donations. This will be evaluated by mixed approach of both qualitative and quantitative methods including staff and donors knowledge and satisfaction of AMT used during a plasma donation to identify if the intervention is still being used as intended.

One-on one open ended audio recorded phone interviews will be conducted with a sample of staff members, and a study specific survey will be sent to all participating staff members. Donors will also receive a study specific survey to complete
Timepoint [2] 323580 0
Staff knowledge and feedback will be assessed via study-specific survey at the end of the 30 week trial and 6 months after the completion of the 30 week trial, Staff satisfaction will also be assessed with a sample of staff in one on one interviews or focus groups (audio recorded) commencing at 3 months after the completion of the 30 week trial,
Secondary outcome [1] 382262 0
Difference between intervention and control groups in the number of donor adverse events (AEs). Known adverse events include phlebotomy injures (e.g.: haematoma), localised infections and citrate reactions. AEs will be recorded either directly by donor centre staff present during the donation or reported directly by the donor post donation to our national call centre.
Timepoint [1] 382262 0
Immediately after blood donation or within 24 hours after donation if a delayed reaction occurs
Secondary outcome [2] 382263 0
Difference between intervention and control groups in Blood Donor Reaction Inventory (BDRI) scores a participant reported outcome

Donors will be assessed on how they feel post donation using the BDRI's 6 item Likert Scale 0-5,
Timepoint [2] 382263 0
within 72 hours post cessation of donation
Secondary outcome [3] 382277 0
Difference between intervention and control group scores of the Blood Donor Self Efficacy Scale a participant reported outcome

Donors will assessed on 8 items on a Likert Scale 1-7 as part of the Blood Donor Self Efficacy scale (France CR, Montalva R, France JL, Trost Z. Enhancing attitudes and intentions in prospective blood donors: evaluation of a new donor recruitment brochure. Transfusion. 2008;48(3):526-30.)
Timepoint [3] 382277 0
within 72 hours post cessation of donation
Secondary outcome [4] 382278 0
Difference between intervention and control groups in length of time taken to complete apheresis procedure. The time taken for each collection is measured from the start of the donation by the automated blood collection system until completion or early termination and recorded by the phlebotomists in the donors electronic record
Timepoint [4] 382278 0
from start to finish of the blood donation
Secondary outcome [5] 382279 0
Difference between intervention and control groups in sub optimal/ underweight collections. The weight of collections are measured at the end of the donation by the automated blood collection system and recorded by the phlebotomists in the donors electronic record
Timepoint [5] 382279 0
Immediately after blood donation
Secondary outcome [6] 382281 0
Difference between intervention and control groups in retention rates (rates of return for subsequent donations). This will be assessed by using Lifebloods National Blood Management Systems donation records
Timepoint [6] 382281 0
4 months from initial donation

Eligibility
Key inclusion criteria
CLUSTERS
1. Donor centres with minimum attendance of 54 plasma donors per week
2. Donor centres using the Aurora machine used as standard plasmapheresis practice for a minimum of 4 weeks to 3 months depending on guidance from the Clinical Hypervigilance team and the Donor Services Leadership Team

PARTCIPANTS
1. Eligible for plasma donation as per the current ‘Guidelines for the Selection of Blood Donors’ (GSBD)
2. Plasmapheresis donation
3. Consent to participate in study (survey component only)

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
CLUSTERS
1. Plasma only donor centres
2. Donor mobile units (DMUs) and demountable mobile units
3. Participation in another research study (R&D or Marketing) that may interfere with donor recruitment and the outcomes under investigation
4. Donor Services Leadership Team consider the donor centre not appropriate for participation (e.g. centre undergoing renovations, relocation)

PARTICIPANTS
1. Donors not donating plasma by apheresis (e.g., whole blood, platelets, sample only)
2. Australian Red Cross Lifeblood staff members

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Donor Collection Centres (Cluster) will be randomised via a Simple randomisation scheme using computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Step Wedge Cluster design
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 305250 0
Charities/Societies/Foundations
Name [1] 305250 0
Australian Red Cross Lifeblood
Address [1] 305250 0
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Country [1] 305250 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Red Cross Lifeblood
Address
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 305608 0
None
Name [1] 305608 0
Address [1] 305608 0
Country [1] 305608 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305593 0
The Lifeblood Ethics Committee
Ethics committee address [1] 305593 0
17 O'Riordan St
Alexandria NSW 2015
Ethics committee country [1] 305593 0
Australia
Date submitted for ethics approval [1] 305593 0
21/02/2020
Approval date [1] 305593 0
27/02/2020
Ethics approval number [1] 305593 0

Summary
Brief summary
International and Australian research has primarily focused on reducing the risk of syncope (fainting) and presyncopal symptoms ( e.g: lightheadedness, dizziness, weakness, nausea) in whole blood (WB) donors. One of the most effective strategies is to instruct donors to use lower body muscle tensing exercises at strategic time points during their donation to increase blood pressure and to distract donors from potential fainting triggers.

To our knowledge, few studies have focused on reducing the risk of fainting in plasma donors. This is especially concerning as the number of faints and pre faints in plasma donors have increased in the last few years due to the increased number of plasma collections and the policy introduced in December 2017 in Australia allowing new donors to go direct to plasma. In 2018, over 8,500 donors experienced a a faint or prefaint while giving plasma in Australia, with the majority occurring in relatively inexperienced donors.

In this trial, we will evaluate the effectiveness of using applied muscle tension (AMT) during a plasma donation in reducing faint and pre-faint symptoms. This study will use a pragmatic type II effectiveness-implementation hybrid (HEI) design. This allows for simultaneous testing of the effectiveness of AMT in reducing faint an pre-faints and to examine organisational perceptions that may increase adoption, implementation and sustainability of AMT in a blood donation setting. By combining the efficacy and effectiveness stages of intervention development, we can ensure more rapid translational gains (i.e. reduction in fainting/ pre-faints) while gathering information regarding the effectiveness of AMT.

Aim 1 - Effectiveness: To determine whether the AMT intervention compared to a business as usual care condition reduces phlebotomist-registered pre-faint and fainting reactions among plasma donors.

Aim 2 - Implementation: To develop strategies to facilitate the implementation and sustainability of AMT in plasma donations at 15 donor centres.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100894 0
Ms Amanda Thijsen
Address 100894 0
Australian Red Cross Lifeblood
Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Country 100894 0
Australia
Phone 100894 0
+61 2 9234 2493
Fax 100894 0
Email 100894 0
BS_ClinicalTrials@redcrossblood.org.au
Contact person for public queries
Name 100895 0
Ms Elizabeth Knight
Address 100895 0
Australian Red Cross Lifeblood
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Country 100895 0
Australia
Phone 100895 0
+61 3 9252 0926
Fax 100895 0
Email 100895 0
BS_ClinicalTrials@redcrossblood.org.au
Contact person for scientific queries
Name 100896 0
Ms Elizabeth Knight
Address 100896 0
Australian Red Cross Lifeblood
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Country 100896 0
Australia
Phone 100896 0
+61 3 9252 0926
Fax 100896 0
Email 100896 0
BS_ClinicalTrials@redcrossblood.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to confidentiality and privacy IPD will not be shared
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7725 0
Ethical approval
Citation [1] 7725 0
Link [1] 7725 0
Email [1] 7725 0
Other [1] 7725 0
Summary results
No Results